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Gabapentin and Chronic Post Surgical Pain (CPSP)

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ClinicalTrials.gov Identifier: NCT03867240
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Cheryl Hartzell, Emory University

Brief Summary:
The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Scoliosis Idiopathic Drug: Gabapentin Other: Placebo Phase 3

Detailed Description:
Pain after surgery can last for a long time. When it lasts for over two months, it is considered chronic postsurgical pain (CPSP). This is a problem in kids and adolescents that can impact many areas of the patient's life and their family. Many patients who undergo surgery for their scoliosis develop CPSP. The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Perioperative Gabapentin in Adolescents Undergoing Posterior Spinal Fusion for Idiopathic Scoliosis to Prevent Chronic Postsurgical Pain, a Pilot Study.
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

Arm Intervention/treatment
Experimental: Gabapentin
Gabapentin is a common neuropathic medication used in the treatment of chronic pain. Gabapentin will be given preoperative and continued for 5 days postoperatively.
Drug: Gabapentin
Gabapentin (10 mg/kg up to 600 mg) will be given 30 minutes prior to being transported to the operating room. The gabapentin will be in the standard liquid with a concentration of 250mg/5mL. Starting postoperative day 1, patients in the experimental group will receive gabapentin three times daily. Dose of gabapentin will be 100 mg for patients <50 kg and 200 mg for patients > 50 kg. Gabapentin will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with gabapentin for the remainder of their doses upon discharge.
Other Name: Neurontin

Placebo Comparator: Placebo
Control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group.
Other: Placebo
Placebo will be given 30 minutes prior to being transported to the operating room. Placebo will be identically appearing to gabapentin. Starting postoperative day 1, control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group. It will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with placebo for the remainder of their doses upon discharge.




Primary Outcome Measures :
  1. Change in NRS for pain intensity score comparing gabapentin and placebo groups [ Time Frame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively ]
    Patient's included in the study will rate their current pain using the numerical rating scale (NRS). With the NRS for pain intensity, the child rates their pain on a zero to 10 Likert scale, with zero being no pain and 10 being the most pain imaginable. A NRS > 4/10 at the time of the survey will be considered positive for CPSP.

  2. Change in FDI score comparing gabapentin and placebo groups [ Time Frame: Baseline (prior to surgery), at 3 months postoperatively, and at 6 months postoperatively ]
    The functional disability inventory (FDI) is a 15 question self-report inventory that assesses the impact of daily pain on activities at home, school, recreational and social domains. Items are rated on a five-point Likert Scale, ranging from 0 to 4, representing no trouble with the activity up to impossible to do the activity. The scores are tabulated, classifying the patient's function as no to minimal disability (0-12), moderate disability (12-29) or severe disability (30-60).


Secondary Outcome Measures :
  1. Total narcotic requirement in the postoperative period in patients receiving gabapentin versus placebo [ Time Frame: Postoperative period up to 1 month ]
    Opioid consumption will be tabulated from the postoperative care unit (PACU), across nursing shifts and cumulative amounts per day. IV morphine will be converted to oral morphine equivalents using a 3:1 ratio or IV hydromorphone will be converted to IV morphine using a 5:1 ratio. Oxycodone will be converted to oral morphine equivalents using a 1:1.5 ratio. All cumulative opioids will be reported as oral morphine equivalents.

  2. Time to ambulation in patients receiving gabapentin versus placebo [ Time Frame: Postoperative period up to 1 month ]
    Time to ambulation will be recorded.

  3. First oral intake in patients receiving gabapentin versus placebo [ Time Frame: Postoperative period up to 1 month ]
    Time to first oral intake will be recorded.

  4. Time to discharge in each group in patients receiving gabapentin versus standard of care [ Time Frame: Postoperative period up to 1 month ]
    Time to discharge will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be aged 10-18 years at the time of surgery
  • Have a diagnosis of idiopathic scoliosis and/or kyphosis
  • Be undergoing elective posterior spinal fusion
  • Have only mild systemic disease

Exclusion Criteria:

  • A diagnosis of neuromuscular scoliosis and/or kyphosis
  • A diagnosis of chronic pain
  • Used opioids in the past 6 months
  • Developmental delay
  • Liver or kidney disease
  • Obstructive sleep apnea
  • Body mass index >40
  • Be pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867240


Contacts
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Contact: Cheryl Hartzell, MD 404-785-5437 cheryl.maenpaa@emory.edu

Locations
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United States, Georgia
Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Cheryl Hartzell, MD    404-785-6670    cheryl.maenpaa@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Cheryl Hartzell, MD Emory University

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Responsible Party: Cheryl Hartzell, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03867240    
Other Study ID Numbers: IRB00106205
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results after de-identification (text, tables, figures and appendices) will be shared. The following related documents will be available: study protocol, statistical analysis plan, analytic code. Data will become available immediately following publication and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis. Request for proposal should be directed to Cheryl.maenpaa@emory.edu.To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Data will become available immediately following publication and ending 5 years following article publication.
Access Criteria: Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Data will be shared for individual participant data meta-analysis.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cheryl Hartzell, Emory University:
Gabapentin
Pain medication
Chronic postsurgical pain
Pediatric
Idiopathic scoliosis surgery
Additional relevant MeSH terms:
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Scoliosis
Pain, Postoperative
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents